Impact of Walking Practice on Persons With PD

Not Applicable

Terminated

• Conditions: Parkinson's Disease
• Interventions: Other: Individualized walking program; Other: Walking program with custom braces.; Other: Walking program with ankle brace

• Registration Number: NCT02113189
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The purpose of this study is to investigate the impact of a specifically designed leg brace on walking endurance in individuals with Parkinson's disease.

Detailed Description

This is a randomized, repeated measures, matched group study. There will be three groups of participants, 20 participants per group, 60 participants total. Group one (G1) will receive custom-fabricated bilateral braces and a standardized home walking/exercise program. Group two (G2) will receive an off-the shelf ankle support and standardized home walking/exercise program. Group three (G3) will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. Subjects will be followed for one year during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 6 months for the duration of the study for testing as well as for other visits as noted in the table below.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-12-21
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Results First Posted: 2019-03-22
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
2. Age between 30 and 90.
3. Ability to walk 150 feet independently over level surfaces with or without an assistive device.
4. Hoehn and Yahr stage 1-4.
5. Less than 10 full heel raises in single limb stance bilaterally.
6. Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.

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Exclusion Criteria

1. Body mass index greater than 40.
2. Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
3. Any other uncontrolled health condition for which gait training is contraindicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized walking program	Individualized walking program	This group will receive a customized walking program.
Walking program with custom braces	Walking program with custom braces.	This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Walking program with ankle brace	Walking program with ankle brace	This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.

Primary Outcome Measures

Name	Time	Method
Change in Distance Walked on 6-Minute Walk Test (6MWT)	6MWT will be done at initial testing and 12 months	Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.

Secondary Outcome Measures

Name	Time	Method
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System	Testing will be done at initial testing and 12 months	Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze temporal and spatial parameters.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory; 🇺🇸 Dallas, Texas, United States